Europe – Intro : Implementation of ISO standards for the identification of medicinal products in Europe

The International Organisation for Standardisation (ISO), Identification of Medicinal Products (IDMP) standards specify the use of standardised definitions for the identification and description of medicinal products for human use. The purpose of these standards is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner, by providing a common product ’language’ for stakeholders to use in their interactions.

The use of ISO IDMP standards is required in accordance with Articles 25 and 26 of Commission Implementing Regulation (EU) No 520/2012. These provisions mandate Member States, marketing authorisation holders and the European Medicines Agency (EMA) to use ISO IDMP standards for the exchange and communication of information on medicinal products.

In order to pursue the implementation of the ISO IDMP standards, EMA has established services to support the management of master data including..